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Insulin Icodec: First Approval
Insulin Icodec: First Approval
Insulin icodec (AWIQLI®) is an ultra-long-acting basal insulin analogue that is being developed by Novo Nordisk for t...
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
Monoclonal Antibody Generation Using Single B Cell Screening for Treating Infectious Diseases
The screening of antigen-specific B cells has been pivotal for biotherapeutic development for over four decades. Conventio...
Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study
Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study
Rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the first line treatments for...
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Stem Cells and Stem Cell-Derived Factors for the Treatment of Inflammatory Bowel Disease with a Particular Focus on Perianal Fistulizing Disease: A Minireview on Future Perspectives
Inflammatory bowel disease remains a difficult disease to effectively treat, especially fistulizing Crohn’s disease....
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
Antisense oligonucleotides (ASOs) are single stranded nucleic acids that target RNA. The US Food and Drug Administration h...
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review
Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by...
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Demonstration of Physicochemical and Functional Similarity of the Biosimilar BAT1806/BIIB800 to Reference Tocilizumab
Tocilizumab is an immunoglobulin G1 monoclonal antibody targeting the interleukin-6 receptor (IL-6R). BAT1806/BIIB800 (toc...
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly
To evaluate the pricing of etanercept (ETN) reference and biosimilar drugs in a changing competitive to monopolized market...
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs
An ambitious reform of the early access (EA) process was set up in July 2021 in France, aiming to simplify procedures and ...
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
CRISPR-Cas System: A New Dawn to Combat Antibiotic Resistance
Antimicrobial resistance (AMR) can potentially harm global public health. Horizontal gene transfer (HGT), which speeds up ...
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab
Biologic therapy involving anti-tumor necrosis factor-α (anti-TNFα) agents has fundamentally changed the managem...
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Research Advances in Stem Cell Therapy for Erectile Dysfunction
Erectile dysfunction (ED) is a common clinical condition that mainly affects men aged over 40 years. Various causes contri...
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
Safety of Biological Therapies for Severe Asthma: An Analysis of Suspected Adverse Reactions Reported in the WHO Pharmacovigilance Database
The management of uncontrolled severe asthma has greatly improved since the advent of novel biologic therapies. Up to Augu...
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
Targeted Gene Insertion: The Cutting Edge of CRISPR Drug Development with Hemophilia as a Highlight
The remarkable advance in gene editing technology presents unparalleled opportunities for transforming medicine and findin...
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies
Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with t...
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System
Anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAbs) have recently been approved for the prevention...
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region
Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriati...
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Nano–Bio Interactions: Exploring the Biological Behavior and the Fate of Lipid-Based Gene Delivery Systems
Gene therapy for many diseases is rapidly becoming a reality, as demonstrated by the recent approval of various nucleic ac...
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
Splice-Modulating Antisense Oligonucleotides as Therapeutics for Inherited Metabolic Diseases
The last decade (2013–2023) has seen unprecedented successes in the clinical translation of therapeutic antisense ol...
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies
Monoclonal antibodies (mAbs) have transformed therapeutic strategies for various diseases. Their high specificity to targe...
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
Correction to: Is the Availability of Biosimilar Adalimumab Associated with Budget Saving? A Difference-in-Difference Analysis of 14 Countries
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International ...
Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?
Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?
We previously proposed that sacituzumab govitecan (SG, Trodelvy®) likely acts as a simple prodrug of systemic SN-38 a...
Unveiling the Biosimilar Paradox of Oncologists’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study
Unveiling the Biosimilar Paradox of Oncologists’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study
Biosimilars offer a cost-effective alternative to original biopharmaceuticals with comparable efficacy and safety. The per...
Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study
Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study
Serplulimab is a novel, recombinant, humanized, monoclonal, anti-programmed death 1 antibody with a similar or better affi...
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
QX006N is a novel, humanized, IgG4κ monoclonal antibody targeting IFNAR1, developed for the treatment of systemic lup...
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and ...
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?
The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of ...
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
CT-P43 is a candidate ustekinumab biosimilar in clinical development. This paper aims to demonstrate equivalent efficacy o...
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
The interleukin-2 (IL-2) cytokine plays a crucial role in regulating immune responses and maintaining immune homeostasis. ...
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Dystrophin- and Utrophin-Based Therapeutic Approaches for Treatment of Duchenne Muscular Dystrophy: A Comparative Review
Duchenne muscular dystrophy is a devastating disease that leads to progressive muscle loss and premature death. While medi...
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